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Able Labs To Withdraw Seven ANDAs; Data Integrity Concerns Cited

Executive Summary

Able Labs "is no longer willing to rely" on the data in some of its approved ANDAs, the generic drug manufacturer said May 23

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Able to divest businesses

FDA rejects Able Labs' plan to return drugs to market by re-validating product development data included in existing ANDAs and says the company would need to resubmit the ANDAs to FDA for a complete review with new data. The process would take up to 18 months, leading Able to state that its plan for reorganization is not feasible. Able plans to sell its businesses to one or more third party purchasers rather than resume manufacturing. Problems stem from an FDA inspection showing Able did not meet established good manufacturing processes; the company announced a voluntary recall of its products in May (1"The Pink Sheet" May 20, 2005, p. 23)...

Able to divest businesses

FDA rejects Able Labs' plan to return drugs to market by re-validating product development data included in existing ANDAs and says the company would need to resubmit the ANDAs to FDA for a complete review with new data. The process would take up to 18 months, leading Able to state that its plan for reorganization is not feasible. Able plans to sell its businesses to one or more third party purchasers rather than resume manufacturing. Problems stem from an FDA inspection showing Able did not meet established good manufacturing processes; the company announced a voluntary recall of its products in May (1"The Pink Sheet" May 20, 2005, p. 23)...

FDA Cites Able For Failing To Reject Out-Of-Specification Drugs, Altering Data

Able Labs routinely failed to reject drugs that did not meet established standards, specifications and quality control criteria, according to FDA inspectional observations included in a "Form 483" report

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